A Barnett Interactive Web Seminar offers you a seamless, secure, multimedia learning experience. These live, instructor-led sessions are designed to be highly interactive, and can be attended by individual attendees or groups at one low cost. No travel, no travel expenses, and no time away from the office!
Data Management: Key Regulations Impacting the Role of the Clinical Data Manager
Upcoming Courses
In conducting clinical research, there are some specific regulations that directly impact the discipline of Clinical Data Management (CDM). 21 CFR Part 11 includes mandatory regulations that govern clinical trials data. It requires a system in which electronic records and signatures are trustworthy, reliable, and secure; electronic signatures that are equivalent to paper records and handwritten signatures executed on paper; a system that discerns invalid or altered records; and signatures that are linked to an electronic record. The “Guidance for Industry—Computerized Systems Used in Clinical Trials,” builds on the importance of information inclusion when utilizing computerized systems. In addition, the recently finalized “Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring” specifically mentions the role that Clinical Data Management is expected to have in assisting in a risk-based monitoring approach. In this web seminar, we will explore the information in these regulations/guidances that will further the understanding of their impact on our current way of working. 
- Define the 21 CFR Part 11 regulations as they impact Clinical Data Management
- Describe what is meant by an electronic signature
- List components defining “computerized systems”
- Identify the Clinical Data Manager’s role in risk-based monitoring
- Examine eSource Implementation from a CDM perspective
- Clinical Data Managers
- Clinical Research Professionals
Denise G. Redkar-Brown, MT
Click here for complete trainer biographies
$695
Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-17-024-L01-P. Released: 5/17.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.
